冻干机操作手册

LYOTK15

OPERATION MANUAL

操作手册

Equipment Name: A utomatic Vacuum Lyophilizer

设备名称: 真空冷冻干燥机

Equipment model: L YOTK15

设备型号：L YOTK15

PREFACE

前言

Thank you for purchasing Truking Lyophilizer.This operation manual introduces how to correctly operate LYOTK15Lyophilizer. Please read this manual carefully and understand safety notice before operation.

感谢您购买楚天科技冻干机。本操作手册介绍了如何正确使用LYOTK15系列冻干机。在使用该产品前，请务必认真阅读本操作手册，并在理解产品的安全注意事项后再使用该产品

Table of contents

T able of contents (3)

1 Safety Related Marks 与安全有关的标记说明 (5)

1.1 Safety notice 安全注意事项 (5)

1.1.1 Before Power-on上电前 (6)

1.1.2 Mechanical Safety机械安全 (7)

1.1.3 Emergency Stop 紧急停止 (7)

1.1.4 Maintenance and Inspection 维护与检查 (8)

2 Lyophilizer Introduction 冻干机简介 (9)

2.1 Purpose 冻干机用途 (9)

2.2 Configuration 冻干机配置 (9)

2.3 Control System 冻干机控制系统 (10)

3 HMI Operation Description上位机操作说明 (11)

3.1 System Introduction 上位机系统简介 (11)

3.2 Operation instruction (11)

3.2.1 Menu Bar 菜单条 (12)

3.2.2 Login登陆 (13)

3.2.3 Log out 登出 (14)

3.2.4 Flow Chart 流程图 (14)

3.2.5 Console 操作台 (16)

3.2.6 PID Control Mimic PID控制画面 (30)

3.2.7 Alarm mimics报警画面 (31)

3.2.8 Trend Mimic曲线画面 (33)

3.2.9 Loading and Unloading 进出料画面 (36)

3.2.10 Setup Mimic设置画面 (38)

3.2.11 Recipe Edit配方编辑 (38)

3.2.12 Recipe running 配方运行 (44)

3.2.13 PLC Input Status PLC输入状态 (45)

3.2.14 PLC Output Status 输出状态 (45)

3.2.15 Recorder 记录仪画面 (46)

3.2.16 Application 应用画面 (46)

3.2.17 Report 报表查询 (48)

3.2.18 Maintenance 维护 (49)

3.2.19 System Configuration 系统配置 (49)

3.2.20 Exit退出 (50)

3.2.21 Status Bar 状态条 (50)

4 Operation Instruction冻干机操作说明 (52)

4.1 Power on 上电 (52)

4.2 Manual Control手动控制 (57)

4.3 Automatic Control 自动控制 (61)

4.3.1 Freeze Drying Cycle冻干周期 (62)

4.3.2 Condenser Defrosting冷阱除霜 (65)

4.3.3 CIP 在线清洗 (67)

4.3.4 SIP在线灭菌 (71)

4.3.5 Vacuum Leakage Test 真空泄漏测试 (75)

4.3.6 Shelf Bellow Test板层波纹管测试 (77)

4.3.7 Main Valve Bellows Iitegrity Test主阀波纹管测试 (78)

4.3.8 Unloading Pusher Bellows Test后推波纹管测试 (79)

4.3.9 Filter1 integrity test 过滤器1完整性测试 (81)

4.3.10 Filter2 integrity test过滤器2完整性测试 (82)

5 Operation Instruction of HMI (85)

5.1 Manual operation interface (86)

5.2 State monitoring interface (87)

6 Alarms and Failures Analysis 常见报警及故障分析 (89)

6.1 PC Failures PC 故障 (90)

6.2 Utility Failures工艺故障 (90)

6.3 Instrumentation Failures仪器仪表故障 (91)

6.4 Device Failure部件故障 (94)

6.4.1 Device State Failure部件状态故障 (94)

6.4.2 Device IO Failure元件IO 故障 (97)

6.5 Process Failure过程故障 (102)

7 Terminology and Abbreviation术语和缩写 (111)

1 Safety Related Marks 与安全有关的标记说明

This manual uses the following marks based on the safety contents.

本手册根据与安全有关的内容，使用了下列标记。

The safety related marks are extremely important to follow.

有安全标记的说明，表示重要内容，请务必遵守。

However, even the attention items may cause major accident based on the actualsituation.

但是，即使是 事项，根据具体情况，有时也可能导致重大事故。

1.1

Safety notice 安全注意事项

Incorrect usage may cause injuries or death.

表示错误使用时，将会引发危险情况，导致人身伤亡。

Incorrect usage may cause mild or moderate personal injury. Moreover the equipment will be damaged.

表示错误使用时，将会引起危险情况，导致轻度或中度人身伤害，损坏设备。

Even items do not belong to “danger” or “attention”, we also mark in the relevant places.

即使不属于“危险”或“注意”，但需要用户遵守的事项，也在相关的地方同时进行了标记。

1.1.1 Before Power-on上电前

components

connect

·请务必确保接地端子接地可靠；否则会有引发触电和火灾的危险。

1.1.2 Mechanical Safety机械安全

The equipment is designed and manufactured following the ISO 12100 part 1, part 2 and ISO 61508 related mechanical safety standards. The specific risk analysis and solutions please refer to FS Mechanical Safety

本设备根据ISO 12100 第1及第2部分、ISO 61508等相关的机械安全标准设计及制造的，具体风险分析及方案请参考FS中机械安全的描述。

1.1.3 Emergency Stop紧急停止

Three emergency stop buttons are mounted in the equipment. One is fitted on the control panel of the cabinet and the other in the control box beside the main door in the machine room. The rest one is shared with the loading/unloading system installed in the sterile room. Once any button is pressed, the hardware interlock of the relevant safety circuit (safety switch+safety relay) will cut off theall the control power except the instrument power. All the power equipments will stop and valves will be in original status (single electric control) or current status (double electriccontrol). All the instruments power will be saved to monitor the equipment status and relevant process parameters. Details are as follows:

三个急停按钮安装在这台设备上，一个安装在控制柜的控制面板上，一个并联到机器房箱体主门旁边的控制盒，另外一个与手动进出料系统共用安装在无菌室内，任何一个被按下后，相应的安全回路（安全开关+ 安全继电器）的硬件连锁将切断除仪表电源外的所有控制电源，所有的动力设备将停止，阀门将处于原始状态（单电控）或当前状态（双电控）。所有仪表电源将被保留以监视设备状态及相关的过程参数，具体如下：

Emergency Stop Reset：紧急停止复位:

After resetting the emergency stop button, alarming confirm button and reset button shall be pressed at the same time. The emergency stop will reset.

复位急停开关后，同时按下电控柜面板上“报警确认按钮”及“复位按钮”，紧急停止将复位。

Make sure the freeze dryer stops before resetting the emergency stop and the failure have 1.1.4Maintenance and Inspection维护与检查

It is extremely dangerous that the cabinet has high-pressured terminals inside. Do not contact

2LyophilizerIntroduction冻干机简介

2.1 Purpose冻干机用途

The lyophilizer is one product integrates freezing technology, drying technology with fluid technology.

冻干机是集冷冻技术、干燥技术、流体技术于一体的产品。

2.2 Configuration冻干机配置

Optional configurations are as follows:

本项目的选项配置如下：

Note:If there is no specific clarification, use ubar，mbar and BarA as vacuum and pressure units for the metric units, and psia as pressure unit for the imperial unit.

注意：如果未明确规定，对于公制单位，使用uBar，mBar和BarA作为真空和压力单位。对于英制单位，使用psia作为压力单位。

2.3Control System冻干机控制系统

3 HMI Operation Description 上位机操作说明

3.1

System Introduction 上位机系统简介

HMI mimic is developed based on the Windows XP operation system, which can assist you with monitoring and controlling the production process, as well as optimizing the production equipment and enterprise resource management. It provides visual production, electronic signature, alarm, and data report, etc, which ensures the stability and reliability of the products.

HMI 界面基于Windows 7 操作系统开发，可以帮助您精确监视控制生产过程，并优化生产设备和企

业资源管理。它提供了可视化生产、电子签名、报警及数据报表等功能，保证产品的稳定可靠性。 3.2

Operation instruction

Operation of the HMI will be described in details in this section. The images in the document may not be consistent with your device.

本节将对上位机操作进行详细描述。文档中的图片与您购买的机型可能不一致。

After opening, the system will automatically monitor withdefault IDL account. The default mimic in diagram 3.1 will be shown in the IPC.

开机后，系统将以默认IDL 账户自动启动监控系统，工控机上出现如图3.1所示默认界面:

Diagram 3.1 Process Mimic (default login mimic)流程界面（登陆默认画面）

Each area and mimic will be described in details in following section

下面对各区域和画面进行详细描述。

Main Mimic 主画面

3.2.1 Menu Bar 菜单条

It provides navigations for different pages. Different monitoring mimics will be shown in main mimic area after clicking each button.

提供不同页面的导航，单击各按钮，将在主画面区域显示不同监控画面。

Table 3.1 lists the operation buttons and functions in the menu bar.

表3.1给出了菜单条的操作按钮名称及其功能

按钮

PLC PLC

Note: If the current button is pressed down, the main mimic enters into the relevant mimic. Repeated click is invalid.

注：若当前按钮显示为按下状态，则表示主画面已进入该按钮所对应画面，再次点击将无效。

3.2.2 Login登陆

The login window shown in diagram3.2 will pop up if clicking the login button. The window will disappear after entering the correct user name and password, and clicking confirmation. The current user will be displayed in the status bar, which means the user has login the system and can operate with the given authority.

点击“登陆”按钮，弹出如图3.2所示登陆对话框。输入正确的用户名和密码，点击“确定”后，对话框消失，状态条上将显示当前用户名，说明该用户已登陆系统，并将按给定的权限进行操作。

Diagram 3.2 Login登陆界面

Note: The login process will be recorded by the system and saved in the operation log.

注：该登陆过程将由系统记录，并保存到操作日志。

3.2.3 Logout登出

Clicking the logout button, the current user will log out. The user name in the status bar will be renewed as IDL.

点击“登出”按钮，当前用户退出控制，状态条上相应用户名恢复为“IDL”。

Note: The logout process will be recorded by the system and saved in the operation log.

注：该登出过程将由系统记录，并保存到操作日志。

3.2.4 Flow Chart流程图

The flow chart mimic contains two parts. One is the main mimic which is the same with lyophilizer P&ID drawing to display the flow system of the lyophilizer. Another part is the footer which displays the relevant information of the automatic cycle. When the system stops and is in manual status, the footer doesn‘t display.

流程图界面包括两部分，一部分为主画面，主画面与冻干机P&ID图一致，以图形方式呈现冻干机流程系统；另一部分为页脚，显示自动周期的相关信息，当系统为停止和手动时，页脚不显示。

a. Main Mimic主画面

The main mimic will be displayed as in diagram3.3 after clicking the process button in the menu bar.

点击菜单条“流程”按钮后，主画面区域显示如图3.3所示画面。

Diagram3.3 Flow Chart流程图画面

In the mimic, the green represents opened or operating components and the red means alarm. For the gray one, it means stop or close as in table 3.2. The following process parameters will be in the flow chart mimic at the same time.

画面中，绿色通常表示部件运行或打开，红色通常表示报警，灰色通常表示停止或关闭，各图例如下表3.2所示。同时，以下过程参数显示在流程图画面中：

1 S helfinlet temperature shall be accurate to one decimal place with ℃ as the unit

板层入口温度，精确到小数点后1位，单位℃

2 S helfoutlet temperature shall be accurate to one decimal place with ℃ as the unit

板层出口温度，精确到小数点后1位，单位℃

3 C ondenser coil temperature 1 shall be accurate to one decimal place with ℃ as the unit

冷阱盘管温度1，精确到小数点后1位，单位℃

4 C ondenser coil temperature 2 shall be accurate to one decimal place with ℃ as the unit

冷阱盘管温度2，精确到小数点后1位，单位℃

5 C hamber drain temperature shall be accurate to one decimal place with ℃ as the unit

箱体排出温度，精确到小数点后1位，单位℃

6 C ondenserdrain temperature shall be accurate to one decimal place with ℃ as the unit

冷阱排出温度，精确到小数点后1位，单位℃

7 F ilterdrain temperature 1 shall be accurate to one decimal place with ℃ as the unit

过滤排出温度1，精确到小数点后1位，单位℃

8 C hamber pressure shall be accurate to two decimal places with BarA as the unit.

箱体压力，精确到小数点后2位，单位BarA

9 C ondenser pressure shall be accurate to two decimal places with BarA as the unit

冷阱压力，精确到小数点后2位，单位BarA

10 C hamber vacuum, unit is ubar

箱体真空，单位ubar

11 P ump head vacuum, unit is ubar

泵头真空，单位ubar

12 S helfposition, unit is N/A

板层位置，单位N/A

流程图图例

pneumatic

Solenoid

b. Footer页脚

It displays some operation information of the automatic cycle for the lyophilizer.

显示冻干机自动周期的一些运行信息。

3.2.5 Console操作台

The console mimic contains operation and parameter modification of the lyophilizer. The main mimic will display as diagram 3.4 if click the operation button in the menu bar.

操作台画面包含冻干机的操作及参数更改，点击菜单条上“操作”按钮，主画面区域将显示如图3.4所示画面。

Diagram 3.4 Console Mimic操作台画面

This mimic contains control mode, control option, automatic control cycle, manual control, manual control parameters, complyingwith the followings:

该画面包括控制模式、控制选项、自动控制周期、手动控制选择、手动控制参数5个部分,并遵循以下规则：

1 All open and close commands of the HMI must pop-up confirming window.

所有上位机开关命令都需要确认弹出框

2 A ll operations in this page conform toelectronic signature.

所有此页面的操作都需要电子签名

3 All the virtual buttons on and off use green and gray color to display able and disable.

所有虚拟按钮开关用绿色和灰色的颜色变化来表现使能和不使能

The mimic mainly includes buttons and textbox. Operation details are as follows:

画面中主要包含按钮和文本框两类操作对象，详细操作说明如下：

1. Operation of the buttons按钮开关的操作

The button switch has two statuses. Gray is disable and green is enable and receiving PLC feedback. Control modes in the mimic: auto and manual. Control options: circulation pump, vacuum controlling the gas, pre-aeration, vacuum control, shelfmovement mode; Auto Control: enabling the freeze drying cycle, suspending the freeze drying cycle,resetting the freeze drying cycle, condenser defrost, CIP, SIP, vacuum leakage test, shelfbellow test. Manual Control: shelftemperature control, condenser cooling, vacuum pump1, vacuum pump2, evacuation valve FV2, isolation valve FV1, vacuum alarm, chamber pre-aeration, chamber aeration, condenseraeration, chamber draining, condenser draining, chamber evacuation, condenser evacuation, main door locking, main door unlocking, slave panel are all this operation mode. The switch has two statuses:

按钮开关有两个开关位置，灰色底色表示未启用，绿色底色表示启用并收到PLC反馈。操作画面中控制模式：自动、手动选择；控制选项：循环泵选择、真空控制气体选择、预放气选择、真空控制选择；自动控制：启动冻干周期、暂停冻干周期、复位冻干周期、冷阱除霜、在线清洗、在线灭菌、真空泄漏测试、板层波纹管测试；手动控制：手动冻干周期、板层控温、冷阱降温、真空泵1、真空泵2、抽空阀FV2、主隔离阀FV1、真

空控制、真空报警、箱体预放气、箱体放气、冷阱放气、箱体排水、冷阱排水、箱体抽空、冷阱抽空、大门锁定、大门解锁、使能控制面板均为该类操作方式。该类开关存在两种状态：

Status Icon Status Icon

Status1 The

drived

receive

feedback.

default stop status.

上位机未驱动，未收到

PLC

认常态

Status2

The HMI is drived

and receives PLC

feedback. It is the

open status.

上位机驱动，

馈，

a. Enable the button switch: the following window will pop up if clicking the button switch. (All the operations need electronic signature and will be saved by the system in the operation log). The user with low access level will be refused to access.

After validating the electronic signature, if the current system satisfies the startup condition (see table3.4 console mimic function description), the confirming window in diagram3.6 will pop up. After confirming the HMI send drives to PLC to start the operation, and the rotary switch is insecond status and it is successfully started. If the current system fails the startup condition, the window(takecondenser for instance: if the manual mode hasn‘t been selected, click the window after starting the condenseraeration) in diagram3.7 will pop up and tell the user why. The user goes back to the operation mimic and eliminates the failure, clicking the button and does the above steps.

按钮开关的启动：单击按钮开关，将弹出电子签名对话框。(注：在该界面中，所有操作都需电子签名，并被系统记录到操作日志中)。此时权限低的用户将被拒绝操作。

通过电子签名验证后，若当前系统满足启动条件（详见表3.4控制台界面功能说明），将弹出确定启用的

对话框，确定后上位机发送驱动给PLC，启动相关操作，旋钮开关呈现第二种状态，启动成功；若当前系统不

满足启动条件，则系统将弹出提示信息框(以冷阱放气为例，在没有选择手动模式的情况下，单击启动冷阱放气

后弹出的信息框)，告知用户不能启动的原因，确定后回到操作画面，用户排除原因后，再次点击按钮开关，重

复上述步骤进行操作。

b. Close the button switch: when the switch is in the second status (receiving the PLC feedback), and clicking the switch can stop the drive. The electronic signature window in diagram 3.5 will pop up after clicking. After passing the electronic signature, the system will inform the user of stopping the control or not, and the stop confirming window in diagram 3.8 will pop up, the switch will go back to the first status after confirmation.

按钮开关的关闭：当开关在第二种状态时（即收到PLC反馈信号时），单击开关可停止驱动。单击后，弹出电子签名对话框，通过电子签名验证后，系统提示用户是否停止控制，弹出停止确认对话框，确认后开关将转为第一种状态。

c. A utomaticallyreset the button switch: Switch doesn‘t need manual stop after some operations. The rotary switch will automatically reset and the operations include: enabling the freeze drying cycle, resetting the freeze drying cycle, condenser defrost, CIP, SIP, vacuum leakage test,

shelfbellow test, main valve bellow test, back pusher bellow test, filter 1 integrity test, filter 2 integrity test in the auto control; chamberpre-aeration, chamber aeration, condenseraeration, chamber draining, condenser draining in manual operation. Other operations must need to manually stop the switch, so the drive from HMO to PLC can be stopped.

按钮开关的自动复位：有些操作完成后，无需手动停止开关，旋钮开关将自动复位，这些操作有：自动控制中的启动冻干周期、复位冻干周期、冷阱除霜、在线清洗、在线灭菌、真空泄漏测试、板层波纹管测试、主阀波纹管测试；手动操作中的箱体预放气、箱体放气、冷阱放气、箱体排水、冷阱排水。其他操作则必须手动停止开关，才可停止上位机对PLC的驱动。

2. Textboxinput文本框数字输入操作

The parameters of the lyophilizer can be manually modified by inputting the number in the textbox. The mimic in diagram 3.9 will pop up after clicking the textbox. The window contains four parts: the first part is to modify the current value; the second part is to display the allowing minimum and maximum value; third part is the keyboard input area; and the last is to confirm or cancel the operation. After inputting the number, the electronic signature window in diagram 3.10 will pop up to inform the user of the modified value and to confirm that.

通过文本框输入数字可以对冻干机手动控制参数进行修改。单击文本框，将弹出数字输入对话框如图3.9

所示。对话框主要分为四部分：第一部分为修改对象的当前值；第二部分显示当前对象允许的最大值和最小值；

第三部分为键盘数字输入区域，第四部分为确定/取消操作。输入数字后，弹出如图3.10所示电子签名验证对

话框，它将提示用户数值会发生变化，并需要进行验证确认。

Diagram 3.9 Textbox input文本框数字输入对话框

Diagram 3.10 Electronic signature电子签名验证对话框

After effective authentication, the variable changes to the inputvalue if the input value is within the range. But the variable will be remained as the original one if the value exceeds the range.

用户输入有效的身份验证后，如果输入的数值在最大值和最小值之间，变量更改为输入值；如果超出范围，则变量维持原值不发生改变。